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PREEMIE: Study for Treatment of PDA in Premature Infants
NCT06587282 · View on ClinicalTrials.gov ↗
Study Summary
This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.
Conditions Studied
Interventions
- DEVICE Bloom Micro Occluder System
Study Locations (10)
California
- UC Davis Health — Sacramento
- UC San Diego-Rady Children's Hospital — San Diego
Florida
- Memorial Healthcare System-Joe DiMaggio Children's Hospital — Hollywood
- Nicklaus Children's Hospital — Miami
Georgia
- Children's Healthcare of Atlanta — Atlanta
Missouri
- Washington University-St. Louis Children's Hospital — St Louis
Ohio
- Nationwide Children's Hospital — Columbus
Tennessee
- Le Bonheur Children's Hospital — Memphis
Texas
- UT Southwestern Medical Center — Dallas
Wisconsin
- Herma Heart Institute-Children's Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-03-06 |
| Est. Completion | 2029-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06587282
The ClinicalTrials.gov registry entry for NCT06587282 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merit Medical Systems, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Patent Ductus Arteriosus (PDA) appearing as the primary indexed condition, and to 1 intervention — of which Bloom Micro Occluder System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06587282 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06587282 about?
NCT06587282 is a clinical study titled "PREEMIE: Study for Treatment of PDA in Premature Infants". This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.
What is the current status of trial NCT06587282?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2025-03-06. Estimated completion is 2029-03.
What conditions does trial NCT06587282 study?
This clinical trial studies the following conditions: Patent Ductus Arteriosus (PDA). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06587282?
The interventions under investigation include: Bloom Micro Occluder System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06587282?
This trial is sponsored by Merit Medical Systems, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06587282 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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